Ando Yuki, Uyama Yoshiaki
Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
J Biopharm Stat. 2012 Sep;22(5):977-87. doi: 10.1080/10543406.2012.701581.
Multiregional clinical trials including Japanese subjects are playing a key role in new drug development in Japan. In addition to the consideration of differences in intrinsic and extrinsic ethnic factors, deciding the sample size of Japanese subjects is an important issue when a multiregional clinical trial is intended to be used for Japanese submission. Accumulated experience suggests that there are several points to consider, such as the basic principles described in the guidance document, drug development strategy, trial phase, and disease background. The difficulty of interpreting the results of Japanese trials should also be considered.
包括日本受试者在内的多区域临床试验在日本新药研发中发挥着关键作用。除了考虑内在和外在种族因素的差异外，当多区域临床试验旨在用于日本申报时，确定日本受试者的样本量是一个重要问题。积累的经验表明，有几个要点需要考虑，例如指导文件中描述的基本原则、药物研发策略、试验阶段和疾病背景。还应考虑解读日本试验结果的难度。
